Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy (REMAP-HCM)
Real-world Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy
The study will describe how mavacamten is used in routine care for Chinese adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), including use as monotherapy or with other background/concomitant oHCM medications.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: First line of the email MUST contain NCT # and Site #.
Sauvegarde des contacts de l'étude
- Nom: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Numéro de téléphone: 855-907-3286
- E-mail: Clinical.Trials@bms.com
Lieux d'étude
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Shanghai, Chine
- Fudan University Zhongshan Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
The study will include adults in China diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) who initiated mavacamten treatment between 24 October 2024 and 31 March 2026.
La description
Inclusion Criteria:
Participants must meet all of the following criteria to be included:
- Diagnosis: Have a documented diagnosis of obstructive hypertrophic cardiomyopathy (oHCM), identified by the corresponding International Classification of Diseases (ICD)-10 codes in the medical record system.
- Medication Exposure: Have a first-ever recorded prescription for Mavacamten within the Patient Identification Period (24 October 2024 to 31 March 2026). This date is defined as the Index Date.
- Age: Be ≥ 18 years of age at the Index Date.
- Treatment Continuity: Have at least two valid clinical records of any type (e.g., outpatient visit, inpatient encounter, prescription refill, laboratory test, or echocardiogram) after the Index Date.
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
(1) Prior Use of Study Drug: Have any documented history of Mavacamten use (based on medical history records, prescription records, or clinical notes) at any time prior to the Index Date.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: RETROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Category A1. Sustained Monotherapy
Participants who initiate mavacamten as monotherapy and remained on monotherapy throughout follow-up. |
As per product label |
|
Category A2. Treatment Intensification
Participants who initiate mavacamten monotherapy and subsequently added one or more background obstructive hypertrophic cardiomyopathy (oHCM) medications during follow-up. |
As per product label |
|
Category B1. Stable Combination Therapy at Initiation
Participants who initiate mavacamten with one or more background obstructive hypertrophic cardiomyopathy (oHCM) medications and remain on combination therapy throughout follow-up. |
As per product label |
|
Category B2. Treatment Simplification
Participants who initiate mavacamten with one or more background obstructive hypertrophic cardiomyopathy (oHCM) medications and subsequently discontinued all background oHCM medications, resulting in mavacamten monotherapy. |
As per product label |
|
Category C. Complex/Unclassifiable
Participants whose treatment records indicate multiple treatment changes that could not be classified into the predefined treatment strategy groups. |
As per product label |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Number of participants in each study cohort
Délai: Baseline and months 1, 2, 3, 6, 9, 12 and 15
|
Baseline and months 1, 2, 3, 6, 9, 12 and 15
|
|
Absolute change (mmHg) from baseline in resting peak left ventricular outflow tract (LVOT) gradient assessed by transthoracic echocardiography
Délai: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
|
Absolute change (mmHg) from baseline in post-Valsalva peak left ventricular outflow tract (LVOT) gradient assessed by transthoracic echocardiography
Délai: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of participants with at least 1-class improvement from baseline in New York Heart Association (NYHA) functional class
Délai: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
|
|
New York Heart Association (NYHA) functional class classification as assessed by the treating physician
Délai: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
|
|
Change from baseline in left atrial dimension (LAD) or left atrial volume index (LAVI) assessed by transthoracic echocardiography
Délai: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
|
|
Change from baseline in interventricular septal thickness (IVST) assessed by transthoracic echocardiography
Délai: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
|
|
Change from baseline in E/e' ratio assessed by transthoracic echocardiography
Délai: Baseline and months 1, 2, 3, 6, 9, 12 and 15
|
Baseline and months 1, 2, 3, 6, 9, 12 and 15
|
|
|
Prescribed mavacamten dose (mg)
Délai: Day 1 and months 1, 2, 3, 6, 9, 12 and 15
|
Day 1 and months 1, 2, 3, 6, 9, 12 and 15
|
|
|
Prescribed mavacamten maintenance dose (mg) during follow-up
Délai: Up to 15 months
|
Up to 15 months
|
|
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Number of participants reaching mavacamten maintenance dose
Délai: Up to 15 months
|
Up to 15 months
|
|
|
Number of participants whose prescribed mavacamten dose changed during the observation period
Délai: Day 1 and and up to 15 months
|
Day 1 and and up to 15 months
|
|
|
Time (days) from Index Date to achieving mavacamten maintenance dose
Délai: Day 1 and up to 15 months
|
Day 1 and up to 15 months
|
|
|
Number of participants that discontinued mavacamten treatment
Délai: Up to 15 months
|
Up to 15 months
|
|
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Time (days) from Index Date to mavacamten discontinuation
Délai: Day 1 and up to 15 months
|
Day 1 and up to 15 months
|
|
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Duration of mavacamten treatment during follow-up
Délai: Day 1 and up to 15 months
|
Day 1 and up to 15 months
|
|
|
Prior hypertrophic cardiomyopathy (oHCM) medication drug class
Délai: Baseline and up to 15 months
|
Drug class of background oHCM medications, including beta-blockers and calcium channel blockers |
Baseline and up to 15 months
|
|
Prior hypertrophic cardiomyopathy (oHCM) medication dose
Délai: Baseline and up to 15 months
|
Dose of background oHCM medications, including beta-blockers and calcium channel blockers |
Baseline and up to 15 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Bristol-Myers Squibb, Bristol-Myers Squibb
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CV027-1262
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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